FoundationOne CDx has earned yet another approval from FDA, making the companion diagnostic now available for 19 FDA-approved targeted therapies. It can now be used as a companion diagnostic for Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. FDA approved Piqray in May 2019, and it is the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer, Novartis reported.
Prasanth Reddy, MD, MPH, CPE, FACP, VP of Medical Affairs at Foundation Medicine Inc., told MD+DI recently that the company’s “tests are for advanced cancer patients and provide information about clinically relevant biomarkers and genomic alterations to help match patients to approved targeted therapies, immunotherapies, and clinical trials—giving doctors and patients powerful actionable insights for navigating cancer care.”
Reddy explained that both the tissue-based test FoundationOne CDx and the blood-based test FoundationOne Liquid can detect guideline recommended genes and biomarkers for patients with breast cancer with ERBB2 (HER2), BRCA1, and BRCA2, and additional alterations in genes known to be relevant in breast cancer, such as PIK3CA, NTRK, ESR1, AKT1, as well as alterations in genes involved in the cell cycle pathway and the PI3K-AKT-mTOR and HER2/EGFR/FGFR pathways.
“Having the broad genomic information about each person’s cancer can help inform treatment decision-making—and we’ve seen exciting advancements in precision medicine in recent years,” he said. “Knowing breast cancer type, often defined by tumor hormone receptor (HR+/-) and HER2 protein status (HER2+/-), is important to understand which class of targeted therapies may help. It’s also important to know your mutation status. For example, a subset of HR+/HER- patients with a PIK3CA mutation—harbored by 40% of this subset—now have a recently approved therapy option. Both HER2 protein status and PIK3CA mutations can be identified by FoundationOne CDx and FoundationOne Liquid.”
When asked whether there would be any data to share on patient outcomes to date, Reddy said that “we believe our genomic profiling tests offer significant clinical utility; they can be particularly impactful if used at diagnosis of advanced disease to help inform personalized treatment planning for each individual patient, but also can be used at the time of progression or recurrence to help identify resistance mechanisms.”
FoundationOne CDx is covered by Medicare and Medicare Advantage beneficiaries who meet eligibility requirements, he said.